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45 CFR 46: Protection of Human Subjects under United States Law (1974)

In the United States, the Code of Federal Regulations Title 45: Public Welfare, part 46 (45 CFR 46) provides protection for human subjects in research carried out or supported by most federal departments and agencies. 45 CFR 46 created a common federal policy for the protection of such human subjects that was accepted by the Office of Science and Technology Policy and issued by each of the departments and agencies listed in the document.

Format: Articles

Subject: Legal

United States v. Georgia (2006)

In United States v. Georgia, the United States Supreme Court held, in a unanimous decision, that the rights protected under the Americans with Disabilities Act, or the ADA, extended to inmates held in state prisons. The Court also abolished sovereign immunity in cases where the Eighth Amendment is involved. The case came about as a result of Tony Goodman, a paraplegic man in a Georgia state prison, who attempted to sue the state under Title II of the ADA.

Format: Articles

Subject: Legal, Ethics, Disorders

Biological Sex and Gender in the United States

In the United States, most people are assigned both a biological sex and gender at birth based on their chromosomes and reproductive organs. However, there is an important distinction between biological sex and gender. Biological sex, such as male, female, or intersex, commonly refers to physical characteristics. Gender refers to the socially constructed roles, behaviors, and actions people take on, usually in relation to expectations of masculinity or femininity. As of 2022, there is disagreement over the relation between sex and gender.

Format: Articles

Subject: Organizations, People, Processes, Ethics

Thesis: The Dynamic Landscape of Abortion Law in the United States

Much change has occurred in abortion laws over the past 50 years, this thesis tracks those changes principally through Supreme Court Cases, such as United States v. Milan Vuitch, Roe v. Wade, and Gonzales v. Planned Parenthood among others. The landscape of abortion law in the US continues to shift today, as recently as 2017 with Plowman v. FMCH cases were being heard in courts that wrought subtle yet important changes in abortion law.

Format: Essays and Theses

Subject: Legal

United States v. Milan Vuitch (1971)

In the 1971 court case United States v. Milan Vuitch, hereafter US v. Vuitch, the US Supreme Court ruled that a Washington, DC law was constitutional by overturning a 1969 district court decision. Beginning in the early twentieth century, Washington, DC, prohibited abortions except for abortions performed to preserve the life or health of the pregnant woman. In 1969, Milan Vuitch, a physician in Washington, DC, was convicted of criminal abortion for providing an abortion when the woman’s life was not endangered.

Format: Articles

Subject: Legal

Sex Determination in Humans

In humans, sex determination is the process that determines the biological sex of an offspring and, as a result, the sexual characteristics that they will develop. Humans typically develop as either male or female, depending on the combination of sex chromosomes that they inherit from their parents. The human sex chromosomes, called X and Y, are structures in human cells made up of tightly bound deoxyribonucleic acid, or DNA, and proteins.

In humans, sex determination is the process that determines the biological sex of an offspring and, as a result, the sexual characteristics that they will develop. Humans typically develop as either male or female, depending on the combination of sex chromosomes that they inherit from their parents. The human sex chromosomes, called X and Y, are structures in human cells made up of tightly bound deoxyribonucleic acid, or DNA, and proteins.

Format: Articles

Subject: Processes, Processes

“General Considerations for the Clinical Evaluation of Drugs” (1977), by the United States Food and Drug Administration

The United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials.

Format: Articles

Subject: Publications

The Development of Silicone Breast Implants for Use in Breast Augmentation Surgeries in the United States

In the 1960s, two plastic surgeons from the United States, Thomas Dillon Cronin and Frank Judson Gerow, collaborated with the Dow Corning Corporation, which specialized in silicone products, to create the first silicone breast implant. Surgeons used the implant, named the Cronin-Gerow implant, to improve the look of a woman’s breasts, by correcting for asymmetry, augmenting the size, or creating a more uplifted profile.

Format: Articles

Subject: Technologies, Processes

A Woman’s Right to Know (2016), by Texas Department of State Health Services

In 2016, the Texas Department of State Health Services, hereafter the DSHS, updated a booklet called A Woman’s Right to Know, which provides information about pregnancy and abortion that physicians must provide to pregnant women who seek an abortion, as part of a mandated informed consent process in Texas. In 2003, the DSHS initially developed the booklet in accordance with the Texas Woman’s Right to Know Act, which is a law that mandates pregnant women receive information about pregnancy and abortion.

Articles

Subject: Publications

Women’s Right to Know Act (2019) by Americans United for Life

In 2019, Americans United for Life, hereafter AUL, published a model legislation, called the Women’s Right to Know Act, in their annual publication Defending Life. The goal of the model legislation, which AUL annually updates, is to help state governments enact enhanced informed consent laws for abortion. The Women’s Right to Know Act requires physicians to provide specific information to women before they may consent to having an abortion.

Format: Articles

Subject: Legal, Publications, Reproduction

Sheppard-Towner Maternity and Infancy Protection Act (1921)

In November 1921, US Congress passed the National Maternity and Infancy Protection Act, also called the Sheppard-Towner Act. The Act provided federal funds to states to establish programs to educate people about prenatal health and infant welfare. Advocates argued that it would curb the high infant mortality rate in the US.

Format: Articles

Subject: Legal, Outreach

HeLa Cell Line

The HeLa cell line was the first immortal human cell line that George Otto Gey, Margaret Gey, and Mary Kucibek first isolated from Henrietta Lacks and developed at The Johns Hopkins Hospital in Baltimore, Maryland, in 1951. An immortal human cell line is a cluster of cells that continuously multiply on their own outside of the human from which they originated. Scientists use immortal human cell lines in their research to investigate how cells function in humans.

Format: Articles

Subject: Technologies, Experiments, People, Ethics

Americans with Disabilities Act (1990)

In 1990, the United States Congress passed the Americans with Disabilities Act, or the ADA, which prohibits discrimination against people with disabilities by employers, governments, or public accommodations. Following gains made during the civil rights movements of the 1900s, people with disabilities sought similar anti-discrimination legislation. The ADA was the culmination of decades of protest and advocacy from the disability rights movement. After the ADA, federal law protected people with an impairment that limited major life functions like sight or mobility from discrimination.

Format: Articles

Subject: Disorders, Organizations, Legal

“Sierra Leone’s Former Child Soldiers: A Longitudinal Study of Risk, Protective Factors, and Mental Health” (2010), by Theresa S. Betancourt, Robert T. Brennan, Julia Rubin-Smith, Garrett M. Fitzmaurice, and Stephen E. Gilman

In 2010, Theresa S. Betancourt, Robert T. Brennan, Julia Rubin-Smith, Garrett M. Fitzmaurice, and Stephen E. Gliman, published “Sierra Leone’s Former Child Soldiers: A Longitudinal Study of Risk, Protective Factors, and Mental Health” in Journal of the American Academy of Child and Adolescent Psychiatry. The paper describes the results of a longitudinal study of former Sierra Leone child soldiers that examines how protective and risk factors affect children’s post-conflict mental health outcomes over several years of development.

Format: Articles

Subject: Publications

Meiosis in Humans

Meiosis, the process by which sexually-reproducing organisms generate gametes (sex cells), is an essential precondition for the normal formation of the embryo. As sexually reproducing, diploid, multicellular eukaryotes, humans rely on meiosis to serve a number of important functions, including the promotion of genetic diversity and the creation of proper conditions for reproductive success.

Format: Articles

Subject: Processes, Reproduction

Dickey-Wicker Amendment, 1996

The Dickey-Wicker Amendment is an amendment attached to the appropriations bills for the Departments of Health and Human Services, Labor, and Education each year since 1996 restricting the use of federal funds for creating, destroying, or knowingly injuring human embryos. The Dickey-Wicker Amendment began as a rider (another name for an amendment) attached to House Resolution (H.R.) 2880. H.R.

Format: Articles

Subject: Legal

George W. Bush Executive Order 13455, June 2007

On 20 January 2001, Republican George W. Bush was sworn in as the forty-third president of the United States, replacing Democrat William J. Clinton. During his eight years in office, Bush issued many executive orders, often altering previous policy. By signing Order 13435 on 22 June 2007, he changed how stem cell research would be performed in America.

Format: Articles

Subject: Legal

United States v. Dennett (1930)

In the 1930 US federal court case United States v. Dennett, Mary Coffin Ware Dennett was cleared of all charges of violating the anti-obscenity Comstock Act, a charge she had incurred by distributing her sex education pamphlet called The Sex Side of Life: An Explanation for Young People. The United States Postal Service charged Dennett under the Comstock Act, which prohibited the distribution of sex-related materials through the mail.

Format: Articles

Subject: Legal

Thesis: Informed Consent Laws for Abortion: What Do Women Have a "Right to Know?

The objective of this project was to determine the importance of informed consent laws to achieving the larger goal of dismantling the right to abortion. I found that informed consent counseling materials in most states contain a full timeline of fetal development, along with information about the risks of abortion, the risks of childbirth, and alternatives to abortion. In addition, informed consent laws for abortion are based on model legislation called the “Women’s Right to Know Act” developed by Americans United for Life (AUL).

Format: Essays and Theses

Subject: Legal, Ethics

“Explaining Recent Declines in Adolescent Pregnancy in the United States: The Contribution of Abstinence and Improved Contraceptive Use” (2007), by John S. Santelli, Laura Duberstein Lindberg, Lawrence B. Finer, and Susheela Singh

In “Explaining Recent Declines in Adolescent Pregnancy in the United States: The Contribution of Abstinence and Improved Contraceptive Use,” hereafter “Explaining Recent Declines,” researchers John S. Santelli, Laura Duberstein Lindberg, Lawrence B. Finer, and Susheela Singh discuss what led to the major decline in US adolescent pregnancy rates from 1995 to 2002. Working with the Guttmacher Institute, a reproductive health research organization, they found that the decline in US adolescent pregnancy rates between 1995 and 2002 was primarily due to improved contraceptive use.

Format: Articles

Subject: Publications, Reproduction

Chapter One and Chapter Two from “Program of Action of the International Conference on Population and Development” (1994), by United Nations Population Fund

“Program of Action of the International Conference on Population and Development” comprises the majority of context within the twenty-year sustainable development plan, International Conference on Population and Development Program of Action, hereafter POA, published in 1994 by the United Nations Population Fund or UNFPA. Given the rising global population, the goal of the POA was to outline the steps governments around the world were to take to achieve sustainable development by 2014.

Format: Articles

Subject: Publications, Outreach

Human Papillomavirus (HPV) Strains 16 and 18

The Human Papillomavirus (HPV) strains 16 and 18 are the two most common HPV strains that lead to cases of genital cancer. HPV is the most commonly sexually transmitted disease, resulting in more than fourteen million cases per year in the United States alone. When left untreated, HPV leads to high risks of cervical, vaginal, vulvar, anal, and penile cancers. In 1983 and 1984 in Germany, physician Harald zur Hausen found that two HPV strains, HPV-16 and HPV-18, caused cervical cancer in women. In the early twenty first century, pharmaceutical companies Merck & Co.

Format: Articles

Subject: Theories

Skinner v. Oklahoma (1942)

In 1942, the United States Supreme Court Case of Skinner v. Oklahoma ruled that states could not legally sterilize those inmates of prisons deemed habitual criminals. Skinner v. Oklahoma was about the case of Jack Skinner, an inmate of the Oklahoma State Penitentiary in McAlester, Oklahoma, who was subject to sterilization under the Oklahoma Habitual Criminal Sterilization Act of 1935. The case, decided on 1 June 1942, determined that state laws were unconstitutional if those laws enabled states to forcibly sterilize inmates deemed to be habitual criminals.

Format: Articles

Subject: Ethics, Legal

“Part-Human Chimeras: Worrying the Facts, Probing the Ethics” (2007), by Françoise Baylis and Jason Scott Robert

In 2007, Françoise Baylis and Jason Scott Robert published “Part-Human Chimeras: Worrying the Facts, Probing the Ethics” in The American Journal of Bioethics. Within their article, hereafter “Part-Human Chimeras,” the authors offer corrections on “Thinking About the Human Neuron Mouse,” a report published in The American Journal of Bioethics in 2007 by Henry Greely, Mildred K. Cho, Linda F. Hogle, and Debra M. Satz, which discussed the debate on the ethics of creating part-human chimeras. Chimeras are organisms that contain two or more genetically distinct cell lines.

Format: Articles

Subject: Organisms, Ethics

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